摘要
目的:采用随机、仿盲、平行对照的原则,观察半导体激光治疗对血瘀证型冠状动脉粥样硬化性心脏病(简称冠心病)的临床疗效和不良反应。方法:①参照2000年中华医学会心血管病学分会、中华心血管病杂志编辑委员会制定的《不稳定性心绞痛诊断和治疗建议》和《中药新药治疗胸痹(冠心病心绞痛)的临床研究指导原则》诊断标准,选择2006-01/02天津中医药大学第二附属医院门诊收治的血瘀证型冠心病患者60例,随机数字表法分为半导体激光治疗组、常规治疗组,30例/组。②常规治疗组使用硝酸酯类、β受体阻滞剂、阿司匹林等常规冠心病心绞痛药物进行治疗,其原来使用的剂量不做任何改变,疗程14d。半导体激光治疗组在常规治疗组的基础上,每天采用半导体激光治疗仪(由北京鹤宝科贸有限公司研制,经国家食品药品监督管理局审查批准,批号20050076)选择波长为650nm的半导体激光作为激光源,以3～5mW的输出功率进行鼻腔内照射,30min/次,1次/d,疗程14d。③观察治疗前后两组患者的心率、血压、中医证候积分、心绞痛症状、治疗心绞痛药物停减率等指标,同时检查心电图。结果:按意向处理分析,60例血瘀证型冠心病患者均进入结果分析。两组患者各项指标临床治疗效果的比较:半导体激光治疗组与常规治疗组心绞痛、心电图总有效率均基本相似(63.3%,50%;50%,36.7%;P均>0.05),但半导体激光治疗组中医证候总有效率明显高于常规治疗组(83.3%,63.3%,P<0.05)。两组在治疗过程中均无毒副作用及不良反应。结论:半导体激光治疗仪对血瘀证型冠心病患者有明显的临床干预效果,能够明显改善神倦乏力等中医证候症状。
AIM： To observe the clinical efficacy and adverse effects of semi-conductor laser nasal：cavity irradiation on patients suffering from the blood-stasis syndrome （BSS） of coronary heart disease （CHD） according to the principle of random, blind and parallel controlled trial.
METHODS： ①Referring to the Diagnosis and Treatment of Unstable Angina and the Clinical Guidance on Chest Stuffiness （Unstable Angina） by National Basic and New Drugs, which were compiled by Chinese Medical Association Cardiovascular Disease Branch and editor committee of Chinese Journal of Cardiology, 60 CHD patients with BSS, who were treated in the Out-patient Department of the Second Hospital Affiliated to Tianjin University of Traditional Chinese Medicine between January and February 2006, were randomly assigned into experimental group and control group, with 30 patients in each.②Thirty patients of control group were given some cardiovascular drugs in common use such as isosorbide dinitrate （ISDN）, beta-receptor blocking agent and aspirin etc in the same administration dose as before. The treatment duration was 14 days. While the patients of experimental group were treated with semi-conductor laser nasal-cavity irradiation （wave length = 650 nm, output power： 3-5 mw） for 30 minutes once everyday plus previous medications of cardiovascular drugs for two weeks. The semi-conductor laser therapeutic apparatus was manufactured by Beijing Jian He Bor Technology and Trade Co., Ltd and approved by State Food and Drug Administration, with lot number of 20050076.③The differences of the heart rate, blood pressure, the integral scores of TCM syndrome, angina clinical symptoms and withdrawal rate of cardiovascular drugs were determined before treatment and after 14 days of treatment respectively, and those patients were examined by electrocardiograph （ECG） at the same time.
RESULTS： According to the intention to treat analysis, all 60 CHD cases with BSS were involved in the final analysis. Comparison of clinical effects in two groups： After treatment, angina and ECG in two groups were not significantly different （63.3%, 50%, 50%, 36.7%, P 〉 0.05）. But the mean total score of TCM syndrome in experimental group was obviously higher than that of control group （83.3%, 63.3%, P 〈 0.05）. And there was no toxic action and adverse effects intwo groups during the treatment.
CONCLUSION： The semi-conductor laser intravascular irradiation has a remarkable ability to intervene the clinical symptoms caused by CHD and improves some TCM symptoms such as fatigue and feebleness.
出处
《中国临床康复》
CSCD
北大核心
2006年第39期36-38,共3页
Chinese Journal of Clinical Rehabilitation
